Efficacy and safety of combination therapy with telmisartan, rosuvastatin, and ezetimibe in patients with dyslipidemia and hypertension: A randomized, double-blind, multicenter, therapeutic confirmatory, phase III clinical trial

被引：1

作者：

Lee, Chan Joo ^{[1
]}

Kang, Woong Chol ^{[2
]}

Ihm, Sang Hyun ^{[3
]}

Sohn, Il Suk ^{[4
]}

Woo, Jong Shin ^{[5
]}

Kim, Jin Won ^{[6
]}

Hong, Soon Jun ^{[7
]}

Choi, Jung Hyun ^{[8
]}

Suh, Jung-Won ^{[9
]}

Seo, Jae-Bin ^{[10
]}

Doh, Joon-Hyung ^{[11
]}

Son, Jung-Woo ^{[12
]}

Park, Jae-Hyeong ^{[13
]}

Lee, Ju-Hee ^{[14
]}

Hong, Young Joon ^{[15
]}

Heo, Jung Ho ^{[16
]}

Shin, Jinho ^{[17
]}

Kang, Seok-Min ^{[1
]}

机构：

[1] Yonsei Univ, Severance Hosp, Dept Internal Med, Div Cardiol,Coll Med, 50-1 Yonsei Ro, Seoul 03722, South Korea

[2] Gachon Univ, Gil Hosp, Dept Cardiol, Inchon, South Korea

[3] Catholic Univ Korea, Bucheon St Marys Hosp, Dept Internal Med, Div Cardiol, Seoul, South Korea

[4] Kyung Hee Univ Hosp Gangdong, Dept Cardiol, Seoul 05278, South Korea

[5] Kyung Hee Univ, Med Ctr, Dept Internal Med, Coll Med, Seoul, South Korea

[6] Korea Univ, Guro Hosp, Cardiovasc Ctr, Div Intervent Cardiol, Seoul, South Korea

[7] Korea Univ, Anam Hosp, Dept Internal Med, Div Cardiol, Seoul, South Korea

[8] Pusan Natl Univ, Sch Med, Div Cardiol, Dept Internal Med, Busan, South Korea

[9] Seoul Natl Univ, Bundang Hosp, Dept Internal Med, Div Cardiol,Coll Med, Seongnam, South Korea

[10] Seoul Natl Univ, Coll Med, Dept Internal Med, Div Cardiol,Boramae Med Ctr, Seoul, South Korea

[11] Inje Univ, Ilsan Paik Hosp, Dept Internal Med, Div Cardiol,Coll Med, Goyang, South Korea

[12] Yonsei Univ, Wonju Severance Christian Hosp, Dept Internal Med, Div Cardiol,Wonju Coll Med, Wonju, South Korea

[13] Chungnam Natl Univ, Sch Med, Chungnam Natl Univ Hosp, Dept Cardiol Internal Med, Daejeon, South Korea

[14] Chungbuk Natl Univ, Coll Med, Dept Internal Med, Div Cardiol,Chungbuk Natl Univ Hosp, Cheongju, South Korea

[15] Chonnam Natl Univ, Chonnam Natl Univ Hop, Div Cardiol, Med Sch, Gwangju, South Korea

[16] Kosin Univ, Gospel Hosp, Dept Internal Med, Div Cardiol, Busan 602702, South Korea

[17] Hanyang Univ, Coll Med, Dept Internal Med, Div Cardiol,Seoul Hosp, Seoul, South Korea

来源：

JOURNAL OF CLINICAL HYPERTENSION | 2024年 / 26卷 / 03期

关键词：

combination therapy; dyslipidemia; ezetimibe; hypertension; rosuvastatin; telmisartan; FIXED-DOSE COMBINATION; BLOOD-PRESSURE; STATIN THERAPY; HYPERCHOLESTEROLEMIA; MANAGEMENT; PHARMACOKINETICS; ATORVASTATIN; METAANALYSIS; METABOLISM; FACTORIAL;

D O I：

10.1111/jch.14778

中图分类号：

R6 [外科学];

学科分类号：

1002 ; 100210 ;

摘要：

This study aimed to compare and evaluate the efficacy of the blood pressure (BP) control and cholesterol-lowering effects and safety of combination therapy with telmisartan, rosuvastatin, and ezetimibe versus rosuvastatin and ezetimibe double therapy or telmisartan single therapy in dyslipidemia patients with hypertension. After a wash-out/therapeutic lifestyle change period of >= 4 weeks, a total of 100 eligible patients were randomized and received one of three treatments for 8 weeks: (1) telmisartan 80 mg/rosuvastatin 20 mg/ezetimibe 10 mg (TRE), (2) rosuvastatin 20 mg/ezetimibe 10 mg (RE), or (3) telmisartan 80 mg (T). The primary endpoint was the efficacy evaluation of TRE by comparing changes in mean sitting systolic blood pressure (msSBP) and mean percentage change in low-density lipoprotein-C (LDL-C) from baseline after 8 weeks of treatment. The least square (LS) mean (SE) changes in msSBP at 8 weeks compared with baseline were -23.02 (3.04) versus -7.18 (3.09) mmHg in the TRE and RE groups, respectively (p < .0001), and -25.80 (2.74) versus -14.92 (2.65) mmHg in the TRE and T groups, respectively (p = .0005). The percentage changes in the mean (SD) LDL-C at 8 weeks compared with baseline were -54.97% (3.49%) versus -0.17% (3.23%) in the TRE and T groups, respectively (p < .0001). No serious adverse events occurred, and no statistically significant differences in the incidence of overall AEs and adverse drug reactions occurred among the three groups. TRE therapy significantly decreased msSBP and LDL-C compared to RE or T therapy with comparable safety and tolerability profiles.

引用

页码：262 / 273

页数：12

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